Avinger (NSDQ:AVGR) said yesterday that it is collaborating with health insurers Highmark Health and Allegheny Health Network to launch a trial of its Pantheris image-guided atherectomy device designed for treating peripheral artery disease. The Pantheris device is designed to use optical coherence tomography to allow physicians to visualize the vessel and obstruction during atherectomy procedures to […]
Vascular
Lombard Medical wins CE Mark for Aorfix AAA stent graft delivery device
Lombard Medical Technologies (NSDQ:EVAR) said today it won CE Mark approval in the European Union for its IntelliFlex low profile delivery system for its Aorfix endovascular stent graft. The system is designed for the delivery of the company’s abdominal aortic aneurysm Aorfix endovascular stent graft, and includes an integrated exchange sheath designed for the delivery of […]
Biotronik wins CE Mark for Magmaris bioresorbable scaffold
Biotronik said today it won CE Mark for its Magmaris magnesium bioresorbable scaffold designed to treat coronary artery disease. Data from the Biosolve-II trial of the stent was previously published in The Lancet, the company said, and 1-year data examining the safety of the device was recently published in The European Heart Journal. “Now that clinical results […]
Silk Road touts TCAR study data
Silk Road Medical disclosed encouraging new clinical data for its Enroute device, which is cleared to help protect the brain from stroke while implanting a transcarotid artery stent. The company said that additional data showed its Enroute transcarotid neuroprotection and stent system, indicated for transcarotid artery revascularization (TCAR), helped improve stroke and death rates in […]
Medtech legend Villafaña is at it again with Medical 21
One of the most prolific and successful entrepreneurs in the medical device space, Manny Villafaña, is at it again with a new startup. Villafaña, the founder of Guidant and St. Jude Medical (NYSE:STJ), among others, said today that his latest venture – Medical 21 – is looking to develop an alternative to harvesting blood vessels for coronary […]
Lombard touts 5-year Aorfix stent graft data
Lombard Medical Technologies (NSDQ:EVAR) yesterday released 5-year results from the Pythagoras trial of its Aorfix, which aimed to evaluate the safety and effectiveness of the stent graft in treating highly angulated aortic necks or tortuous aortoiliac anatomy. A presentation based on data from the study was presented at the 2016 Society for Vascular Surgery’s annual meeting […]
Terumo buys Sequent Medical for $280m
Terumo Corp. (TYO:4543) said today it picked up Sequent Medical, developer of the Web aneurysm embolization device, for $280 million. The Web implant is made of a Nitinol mesh that is delivered in a “stent-like” manner and deployed into the pouch formed by an aneurysm in order to prevent blood from flowing in. Sequent won […]
Medtronic launches Valiant Evo TAA device trial
Medtronic (NYSE:MDT) said today it enrolled the 1st patient in a trial of its Valiant Evo thoracic stent graft system designed for the minimally invasive repair of descending thoracic aortic aneurysms. The 1st procedure in the trial was performed recently at the Univeristy of Texas Health Science Center at Houston by principal investigator Ali Azizzadeh, […]
Intact Vascular launches clinical trial of Tack system
Intact Vascular said today it launched the Tack Optimized Balloon Angioplasty III clinical trial investigating its Tack endovascular system along with Medtronic‘s (NYSE:MDT) Admiral drug-coated angioplasty balloon for treating peripheral arterial disease. The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair […]
Gore wins CE Mark for Excluder stent graft
W.L. Gore & Associates said today it won CE Mark approval in the European Union for its Excluder conformable device designed to treat abdominal aortic aneurysms in patients with challenging anatomies. The newly cleared Excluder device won approval for patients with either proximal aortic neck angles of up to 90 degrees or a minimum aortic […]
Avenu Medical wins CE Mark for Ellipsys vascular access system
Vascular access system maker Avenu Medical said today it won CE Mark approval in the European Union for its Ellipsys vascular access image-guided catheter system designed to percutaneously create arteriovenous fistulas for hemodialysis access. The company also said it won investigational device exemption approval from the FDA for the device, claiming it is the 1st device […]